Regulatory News from Across Asia-Pacific

On 04.02.2020, the authorities SAMR (State Administration for Market Regulation) and CNCA (China National Certification Administration) published in their Notice No 9/2020 general support measures to contain the corona virus outbreak. Chinese certification organizations are bound by these requirements.The measures include:

• Processes are to be optimized so that personal contact is reduced as much as possible.
• Factory inspections by a Chinese certification organization, which must be postponed due to the current situation, must be communicated openly with the affected certificate holders in order to fix an alternative date by mutual agreement. Or other solutions are agreed upon.
• Applications for factories that have stopped production due to the outbreak and are unable to complete an inspection of their manufacturing plant in order to obtain the desired certification (e.g. CCC - China Compulsory Certification), but are subject to a time limit for this, may not be suspended. The necessary inspection should be completed at the latest 3 months after the official announcement that the state of emergency has been lifted.

On 27.12.2019, the China Ministry of Finance, General Administration for Market Regulation and 11 other ministries announced (No.96-2019) the List of Cross-border E-commerce Retail Imported Commodities (2019 edition) covering a total of 1413 types of commodities. The list added roughly 100 types of goods, and removed 8 types from the 2018 edition. According to China Customs, products on the list are exempted from submitting related import licenses. When entering the special trade zone, the commodites on the list will be checked by customs in accordance with the standard procedures for clearing commodities, but will then be exempted when leaving the special trade zone. The updated list came into effect on 01.01.2020.On 24.12.2019, the Chinese State Council announced (No.36-2019) that the State Taxation Administration had approved the establishment of 24 pilot cross-border e-commerce (CBEC) zones - in addition to the 35 pilot CBEC zones that have previously been established - and introduced exemptions on value-added tax and consumption tax for retail and exported goods. The approved document announces the initial plan of how the trial zones will be constructed and replicated across China. More detailed information regarding tax rebates, government support, and international logistic services are expected to follow after this announcement.Please do contact us to know if your products are involved.

On 06.11.2019, the China NDRC (National Development and Reform Commission) announced (No.20-2019) the prohibition of daily chemical articles containing plastic microbeads for production after December 31, 2020, and for sale after December 31, 2022.Microbeads are small plastic particles, mostly included in cosmetic and cleaning products, and are known to cause water pollution to the marine and freshwater environments. Currently, 14 states have already taken action towards the ban on microbeads. Although the details of the ban for production and sales in China is still subject to further refinement, brands and manufacturers are expected to reformulate their products containing microbeads, while some have already replaced microbeads with natural abrasives as an alternative in daily chemical articles.The announcement (No.20-2019) is based on the Industrial Structure Adjustment Guidance Catalogue (2019 Edition) that was approved at the 2nd committee meeting on 27.08.2019, and has replaced the 2011 version since 01.01.2020.

On 20.12.2019, the China NMPA (National Medical Products Administration) announced (No.91-2019) that it would add 148 medical devices and 23 in-vitro diagnostic reagents to the clinical trial exemption list, as well as to revise the names and descriptions of 48 medical devices and 4 in-vitro diagnostic reagents. Medical devices and in-vitro diagnostic reagents on the clinical trial exemption list won’t require completion of clinical trials in order to achieve NMPA certification.This new clinical trial exemption list is effective since the date of announcement on 20th December.Feel free to contact us if you would like to know what products were included in the clinical trial exemption list for medical devices, and the clinical trial exemption list for IVDs.

On 08.11.2019, the SAMR announced the interim implementation of Administrative Measures for Product Quality Spot Inspections (No.18-2019) and Consumer Goods Recall Management (No.19-2019).The Administrative Measures for Product Quality Spot Inspections adopts the sampling inspection process on e-commerce platforms as listed, but not restricted to the following:- The inspector authorized by SAMR can initiate the sampling process by online purchasing the sample as a consumer- The inspector authorized by SAMR should document the e-commerce account, address, and contact information used for online purchasing the sample,and all information should be documented by screenshot, photo taking or video recording- The process from receiving to unpackaging the parcel of the sample product should be recorded by photo taking or video recordingConsumer Goods Recall Management replaces the Administrative Provisions on the Recall of Children's Toys with refinements made applicable for all consumer products. The original Administrative Provisions on the Recall of Children's Toys was released on 27.08.2007, and will be abolished once the Consumer Goods Recall Management comes effective.Administrative Measures for Product Quality Spot Inspections and the Consumer Goods Recall Management will commence on 01.01.2020.

On 22.11.2019, China's NMPA (National Medical Products Administration) announced a draft regulation concerning overseas inspection for cosmetic products, and launched the public consultation to receive feedback.According to the proposed regulation, it aims to introduce, standardize and optimize the inspection process. Once adopted, inspections on foreign manufacturers are required to be conducted by Chinese authorities from NMPA, which includes on-site inspections for any overseas facilities involved with the manufacturing process of cosmetic products that are intended to be sold in the China market.China NMPA will continue to solicit public opinions until 22.12.2019.

From October 25^th to November 1^st, China SAMR publicly solicited opinions upon its release of the third draft on the measures of advertising review management for health food, FSMP, drug products and medical devices.SAMR had been open to public feedback from March 13^th to April 13^th and June 6^th to June 26^th followed by adjustments made to the first and second draft.As revealed in the previous announcement and drafts, SAMR aims to formulate a major regulatory reference in future by requiring compliance for advertising health food, FSMP, drug products and medical devices including, but not limited to, the following conditions:Content (e.g. name, application scope, composition):

• Must match the details in NMPA registration documents, certificate and IFU
• Must be legal and truthful
• Must not mislead or deceive users

Disclaimers necessary:

• Personal use devices:g. ‘Please read the instructions before using the device’ or ‘Please seek the advice of a healthcare professional when buying and using this device’
• If safety instructions & precautions are mentioned in NMPA certificate, they must be displayed clearly in the advertisement

e.g. ‘Please read carefully the precautions before using the device’Approval number of the advertisement:

• Must be clearly indicated in the advertisement

For further information on the above topic, please contact us.

On 10.09.2019, the NMPA (National Medical Products Administration) announced changes to the procedures regarding cosmetics sample tests in China (No. 72-2019), followed by an interpretation of their announcement on 12.09.2019. Laboratories - that perform sample tests for cosmetics NMPA approval - need to re-apply for their qualification as a testing institutions because the relevant qualification will be automatically suspended on 01.11.2019. Until then - during the transitional period - there are two possible methods for managing tests. Cosmetics enterprises can follow the original procedures offline, as well as apply for sample tests online. Starting on 01.11.2019, however, laboratories have to be newly accredited. Furthermore, cosmetics enterprises and their NMPA Legal Agents will only be able to apply for and manage tests, which are related to cosmetics registration/filing, online.1) The goal is to improve the testing workflow, to standardize the test project requirements, to improve the efficiency of tests, and to provide strong technical support for cosmetics safety supervision.2) The prerequisite for testing institutions is to submit relevant information and obtain a new certification from the CMA (China Inspection Body and Laboratory Mandatory Approval).3) New guidelines for testing institutions include that testing must not be subcontracted, quality management system has to be ensured, testing work procedures for cosmetics registration and documentations have to be standardized, the facilities and equipment have to meet requirements.4) In order to improve work efficiency, an “Inspection Information System” was introduced to optimize the workflow of testing institutions. Via the online system, cosmetics manufacturers select a testing institution, submit relevant product information and apply for testing. The testing institution can then accept the test application and issues the test report online after testing.5) Changes in managing test samples include:Firstly, rather than regulatory authorities performing the on-site test sample sealing, the testing insitution seals the test samples. This change only applies to domestic “special” cosmetics.Secondly, laboratories accept samples produced for the purpose of testing if the product is not sold yet. (Please note, however, that the NMPA requires a product to be already sold in the country of origin.)6) The test requirements are changed to emphasize the safety of products during evaluation and some test items will be adjusted to better reflect the safety situation of products; for instance, by measuring dioxane.7) During the transition period – until 31.10.2019:Firstly, testing institutions should apply for their qualification because on 1 November, the old ones will be terminated.Secondly, already approved cosmetics, whose tests do not comply with the new specifications anymore, have to undergo supplementary testing a year of the announcement.Third, cosmetics manufacturers can follow the old (offline) way of applying for and managing tests, as well as the new “online” way.

In accordance with the NMPA (National Medical Products Administration) publication No. 66-2019, the UDI (Unique Identification System) will be mandatory for medical devices in China as of 01.10.2019.There are currently the following two relevant guidelines:• Rules for the Unique Identification System of Medical Devices• YY / T 1630-2018 Fundamental Requirements for UDI The UDI code application has to be submitted to ANCC (Article Numbering Center of China). Starting 01.10.2019, the registered UDI code has to be provided to the NMPA as part of initial registration, renewal or change applications. Prior to exporting to China, all newly registered products must be labeled with the UDI code.